Indication:
U.S.FDA APPROVED DRUGS APPROVED FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
175. Ceftriaxone 18-08-08
+ Sulbactum injection
(Addl.indication)
For the treatment of acute bacterial otitis media,
skin & soft structure infections ,UTI, uncompliacted
gonorrhoea,pelvic inflammatory disease, bacterial
septicemia, bone and joint infections,intra abdominal
infections, meningitis,surgical prophylaxis
U.S.FDA APPROVED DRUGS DURING 2006
72. Ceftriaxone ( as sodium) 250mg + 05-07-2006
azobactam 31.25mg for injection (addl.stgth) Anti-biotic
U.S.FDA APPROVED DRUG DURING 2007
31. Ceftriaxone (as sodium)125mg/250mg + 01-03-2007
Sulbactum (as sodium ) 62.5mg/125mg
Injection (addl.stgth)
As approved
167. Ceftriaxone 2gm + 21-11-07
Tazobactum 250mg for injection As approved
A third generation drug
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Ceftriaxone - Antibiotic April 1988
Sodium
2. Ceftriaxone sodium 01-03-2007
125mg/250mg + sulbactum as sodium
62.5mg/125mg for injection
Addl.Strgth
As approved
3. Ceftriaxone as sodium 250mg + 05-07-2006
Tazobactum 31.25mg for injection
Addl.stgth
Antibiotic
4. Cetriaxone + sulbactum injection 18-08-2008
Addl indication
For the treatment of acute bacterial otitis media, skin & soft
structutre infections, UTI, uncomplicated gonorrhoes, pelvic
inflammatory disease, bacterial septicemia, bone and joint
infections, intra abdominal infections, meningitis, surgical
prophylaxis
5. Cetriaxone 2gm + Tazobactum 21-11-2007
250mg for injection
As approved
6.Cetriaxome sodium equiv. to 21-09-2011
ceftriaxome sodium 1000mg/2000mg +
Sulbactum sodium equiv. to sulbactum
500mg/500mg
Addl Indication
For the treatment of urinary tract infections and lower respiratory
tract infections, variuos bacteria
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Ceftriaxone sodium 500mg/1000mg + 12-08-2005
Sulbactum sodium 250mg/500mg for injection
For LRTI
2.Ceftriaxone sodium 250mg+ 07-05-2006
Tazobactum 31.25mg for injection
Addl.Stgth
Anti-bacterial
3.Ceftriaxone 0.125/0.25/0.5/1g + 21-07-2005
Tazobactum 15.625/31.25/62.5/125mg injection
For the treatment of patients with community acquired pneumonia
and lower respiratory tract infection
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.FDC of Ceftriaxone 500mg/1000mg + 21-07-2005
Tazobactum 62.5mg/125mg Injection
Antibacterial
Post operative infections.
Drugs covered:
1st generation 2nd generation 3rd generation . Cephalexin Cefaclor Cefixime Cefadroxil Cefamandole Cefoperazone Cephadrine Cefotoxitin Cefotaxime Cephalothin Cefuroxime Ceftizoxime Cephapirin Cefonicid Ceftriaxone Cefazolin Cefmetazole Ceftazidime Cefotetan Ceftibuten Cefprozil Cefepime Cefpodoxime Loracarbef
Refer Cephalosporins